Data / Medical devices / Canada / Orthopediatrics Canada ULC
Orthopediatrics Canada ULC: FDA-registered device maker in Laval Quebec, Canada, 13 510(k) clearances
Orthopediatrics Canada ULC is registered with the FDA (registration 3000327445) in Laval Quebec, Canada. It lists 16 device types. The FDA files 13 510(k) clearances under its listings, the newest dated February 21, 2025. 11 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3000327445
- Address
- 1111 Chomedey Highway (A13), Laval Quebec, Canada, H7W 5J8
- Owner or operator
- Pega Medical Inc. (10027933)
- Roles
- Manufacturer
- First device listed
- December 16, 2008
- Registered through
- 2027
- Brand names listed
- Dr.Paleys Osteotomy System, FASSIER-DUVAL TELESCOPIC IM SYSTEM, FREE GLIDING SCFE SCREW SYSTEM, Fassier-Duval Telescopic IM System, Fassier-Duval Telescoping IM System, Fassier-Duval Telscopic Im System, Fassier-Duval Telscopic Im System Instruments, Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Manufacturer | accessdata.fda.gov |
| Awl | HWJ | 1 | Manufacturer | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Manufacturer | accessdata.fda.gov |
| Bone Mill | LYS | 1 | Manufacturer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Manufacturer | accessdata.fda.gov |
| Extractor | HWB | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Manufacturer | accessdata.fda.gov |
| Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | OBT | 2 | Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Manufacturer | accessdata.fda.gov |
| Reamer | HTO | 1 | Manufacturer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer | accessdata.fda.gov |
| Trephine | HWK | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 21, 2025 | K241983 | Fassier-Duval Telescoping IM System | HSB | Substantially Equivalent | Orthopediatrics Canada Ulc Dba Pega Medical | accessdata.fda.gov |
| October 24, 2022 | K220190 | The GIRO Growth Modulation System | OBT | Substantially Equivalent | Pega Medical, Inc. | accessdata.fda.gov |
| May 26, 2021 | K211292 | Fassier-Duval Telescopic IM System | HSB | Substantially Equivalent | Pega Medical, Inc. | accessdata.fda.gov |
| June 24, 2020 | K192710 | The Simple Locking Intramedullary (Slim) System | HSB | Substantially Equivalent | Pega Medical, Inc. | accessdata.fda.gov |
| September 8, 2017 | K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) System | KTT | Substantially Equivalent | Pega Medical, Inc. | accessdata.fda.gov |
| March 16, 2017 | K163003 | Y3 Proximal Femoral Plate System | HRS | Substantially Equivalent | Pega Medical, Inc. | accessdata.fda.gov |
| November 23, 2016 | K160545 | GAP ENDO-EXO MEDULLARY SYSTEM | HSB | Substantially Equivalent | Pega Medical, Inc. | accessdata.fda.gov |
| July 10, 2015 | K143355 | The Simple Locking IntraMedullary (SLIM) System | HSB | Substantially Equivalent | Pega Medical, Inc. | accessdata.fda.gov |
| November 27, 2013 | K131591 | FREE GLIDING SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREW (SCFE) | HWC | Substantially Equivalent | Pega Medical, Inc. | accessdata.fda.gov |
| January 26, 2012 | K111232 | GAP ENDO-EXO MEDULLARY SYSTEM | HSB | Substantially Equivalent | Pega Medical, Inc. | accessdata.fda.gov |
| May 20, 2009 | K090440 | HINGE PEDIATRIC PLATING SYSTEM | HRS | Substantially Equivalent | Pega Medical, Inc. | accessdata.fda.gov |
| August 17, 2004 | K041393 | FASSIER-DUVAL TELSCOPIC IM SYSTEM | HSB | Substantially Equivalent | Pega Medical, Inc. | accessdata.fda.gov |
| February 6, 2003 | K020885 | FASSIRE-DUVAL TELESCOPIC IM SYSTEM | HSB | Substantially Equivalent | Pega Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 4, 2024 | 95077 | Class II | Ongoing | FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System | During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX. | accessdata.fda.gov |
| April 3, 2020 | 85531 | Class III | Terminated | Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures. | The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label. | accessdata.fda.gov |
| October 2, 2019 | 84017 | Class II | Terminated | SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery | There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out. | accessdata.fda.gov |
| May 29, 2019 | 83372 | Class II | Terminated | SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System | Handle could jam with the Driver due to the detachment of an internal Connector Ring. | accessdata.fda.gov |
| October 20, 2015 | 72529 | Class II | Terminated | SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked | SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw. | accessdata.fda.gov |
| June 15, 2015 | 71560 | Class II | Terminated | Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273. | SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high torques are applied in counter-clockwise rotation. | accessdata.fda.gov |
| April 10, 2015 | 71061 | Class II | Terminated | Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument | The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage. | accessdata.fda.gov |
| February 20, 2015 | 70630 | Class II | Terminated | GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures | Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of the distal cortical screw holes. Failures mainly occurred in patients with tibial pseudoarthrosis (CPT) or Osteogenesis imperfecta (OI). Higher failure rates have been detected in tibias with distal fractures that are close to the distal locking holes. | accessdata.fda.gov |
| March 5, 2014 | 67803 | Class II | Terminated | Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue number FD-040(L)-SS. -Duval IM Telescopic System. | The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the product contained in the package. | accessdata.fda.gov |
| February 7, 2014 | 67675 | Class II | Terminated | Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod. | The Male Components in this lot are made of material with lower strength than manufacturing specifications. | accessdata.fda.gov |
| January 29, 2010 | 54620 | Not yet classified | Terminated | Male Driver 4.0mm (catalog # MDr140L) and Male Driver 3.2mm (catalog # MDr132L), an instrument used for the insertion of the Fassier-Duval Telescopic IM System intramedullary nail, for bone fixation. | Possible breakage. Structural weakness has been detected on the Male Driver 3.2mm and 4.0mm sizes. In certain cases, this weakness could lead to a premature failure of the instrument if it is submitted to large torsional loads higher than the normal forces required to introduce the male component. | accessdata.fda.gov |
Compare with other makers
- All makers of Passer, Wire, Orthopedic
- All makers of Reamer
- All makers of Plate, Fixation, Bone
- All makers of Screw, Fixation, Bone
- All makers of Cutter, Wire
- All makers of Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Updated February 21, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.